Currently there is no completely integrated, affordable, point-of-care (POC) or point-of-need diagnostic platform that is rugged, durable, and that provides results in minutes with a high level of sensitivity and specificity that may be operated with little training. This problem applies to diagnosing/detecting bacteria, viruses, fungi, pathogens, biomarkers and industrial processes, as well as chemical and biological warfare agents. Existing diagnostic platforms are very expensive in terms of both the equipment and the actual test performed, require a laboratory or hospital setting, require highly trained technicians, require expensive infrastructure, and take from hours to days to obtain results. This current time to deliver results and the current cost of getting these results ultimately means lost lives, health, and money when utilizing current technologies.
Recent development with existing detection technologies of biological binding events and cellular activity have improved over time to the point where they are now limited by the first principles of the binding affinity of the targets or targeted pairs (e.g., antibody-antigen, etc.), or the amount of cellular activity when measuring metabolic activity. The weaker binding events and lower cellular metabolic rates are below the noise floor of these technologies, however, thereby rendering it hard to impossible to detect such events as those limits are reached. Therefore, it is critical to integrate robust enzyme amplification strategies with micromachined calorimeters with a small thermal mass and fast response times into future assay technologies.